Prospective, multi-country, observational registry to collect clinical

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46710
• EU PAS number:
  EUPAS21731
• Study ID:
  46710
• Official title and acronym:
  Prospective, multi-country, observational registry to collect clinical
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Croatia

  Czechia

  France

  Germany

  Italy

  Netherlands

  Portugal

  Spain

  Sweden
• Study description:
  To collect clinical information in patients with Cushing’s syndrome (CS) exposed to ketoconazole, to assess drug utilization patterns and to document the safety, and effectiveness of ketoconazole. The primary objective is to collect and assess safety data with a particular focus on the important identified risks of hepatotoxicity and QT prolongation. The secondary objectives are to collect and assess other safety data, to evaluate the effectiveness and drug utilization patterns of ketoconazole.
• Study status:
  Ongoing

Research institution and networks

Institutions

HRA Pharma Rare Diseases

University of Bordeaux

France

University Hospital Centre Zagreb (KBC Zagreb)

Croatia

Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau

Charité-Universitätsmedizin

Erasmus Medical Centre Rotterdam

Hôpital de la Conception Marseille Centre Hospitalier Universitaire de Bordeaux, Hôpital Bicêtre Paris University Hospital Zagreb, Hôpital Universitaire de Grenoble Dr Sahlgrenska University Hospital Goteborg, Hôpital Cochin Paris Centro Hospitalar de Lisboa Ocidental, Institut de Recerca de la Santa Creu i Sant Pau Barcelona Hospitalar Universitário de Coimbra, Hospital clinic Barcelona Centro Hospitalar Universitário do Porto, Hospital Universitario de La Ribera University Hospital in Prague, Hospital General Universitario Gregorio MaranonMadrid Charité Universitatsmedizin Berlin, Hospital Universitario de Albacete Klinikum der Universitat München, Erasmus University Medical Center Rotterdam MEDICOVER Oldenburg MVZ- Oldenburg

Networks

ERCUSYN

Study timelines

Date when funding contract was signed

Planned: 29/12/2017

Actual: 31/07/2018

Study start date

Planned: 01/03/2018

Actual: 01/11/2018

Date of interim report, if expected

Planned: 01/11/2018

Actual: 29/10/2018

Date of final study report

Planned: 01/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

HRA Pharma Rare Diseases

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/003906/ANX/002,EMEA/H/C/PSP/0040